Optimisation of the Treatment of Infectious Bursitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406652
Recruitment Status : Unknown
Verified June 2011 by University Hospital, Geneva.
Recruitment status was:  Recruiting
First Posted : August 1, 2011
Last Update Posted : August 1, 2011
Information provided by:
University Hospital, Geneva

June 27, 2011
August 1, 2011
August 1, 2011
May 2011
June 2014   (Final data collection date for primary outcome measure)
Reduction of total costs associated with one-stage treatement of septic bursitis [ Time Frame: Patients will be followed-up during hospital stay and during 2 months after discharge ]
Onestage bursectomy is associated with significantly reduced costs of overall treatement of septic bursitis compared to a two-stage approach. The cost reduction concerns probably all strata of cost evaluation: surgery and anesthesiology costs, nursing costs, costs related to postoperative follow-ups, medication use, and absence from work
Same as current
No Changes Posted
Equivalence of one-stage bursectomy compared to two-stage bursectomy in terms of recurrence [ Time Frame: Patients will be followed-up during hospital stay and during 2 months after discharge ]
The one-stage approach does not only reduce costs, but harbors equally remission/cure rates of septic bursitis than the two-stage approach.
Same as current
Not Provided
Not Provided
Optimisation of the Treatment of Infectious Bursitis
One-stage Versus Two-stage Surgical Treatement of Infectious Bursitis

Th study investigates prospectively the cost-savings related to a one-stage bursectomy (debridement, drainage and closure at the same time) versus two-stage bursectomy (debridement, left open and closure at a second time) of severe bursitis among hospitalized patients for surgical treatment of septic bursitis.

We suppose that the one-stage bursectomy reveals similar recurrence rates but is associated with a significant shortening of hospital stay, consumption of resources and increased patient satisfaction.

Start as single center interventional study at Geneva University Hospitals Study open for additional centres (electronic CRF) Funding on 24.6.2011 (50,000 Swiss Francs). Further demand for funding ongoing.

Spetic bursitis of knee and elbows, for which the patients are hospitalised (a substantial part of patient with failure of conservative treatement) Randomisation 1:1 (one-stage vs. two-stage).

Duration of concomitant postsurgical antibiotic therapy fixed to 7 days Exclusion of severely immuno-depressed patients.

Assessment of all costs of inpatient treatement and outpatient follow-up of included cases.

Interim analysis after ca. 100 cases planified

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Olecranon Bursitis
  • Patellar Bursitis
Procedure: Two-stage bursectomy
Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions
Other Name: There are no "other names"
Experimental: One-stage bursectomy
Bursectomy with debridement and primary closure of the wound during one surgical intervention
Intervention: Procedure: Two-stage bursectomy

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2014
June 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age >18 years
  2. Hospitalized for bursectomy for septic bursitis

Exclusion Criteria:

  1. Bacteraemic diseases
  2. Presence of another concomitant infection requiring antibiotics
  3. Presence of osteosynthesis material beneath the bursitis
  4. Spetic bursitis outside of the elbow or the knee
  5. Severe immune suppression (transplantation, HIV with CD4 count <200 cells/mm3, immune suppressive treatement with aequivalence of more than 15 mg of prednisone daily ).
  6. Recurrent septic bursitis episodes
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
11-016 (NAC 11-004)
Not Provided
Not Provided
Ilker UCKAY, MD, Geneva University Hospitals
University Hospital, Geneva
Not Provided
Principal Investigator: Ilker UCKAY, MD University Hospital, Geneva
University Hospital, Geneva
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP